On-treatment comparison between corrective His bundle pacing and biventricular pacing for cardiac resynchronization: A secondary analysis of the His-SYNC Pilot Trial

His-SYNC Investigators

doi:10.1016/j.hrthm.2019.05.009

On-treatment comparison between corrective His bundle pacing and biventricular pacing for cardiac resynchronization: A secondary analysis of the His-SYNC Pilot Trial

His-SYNC Investigators

Medicine, Cardiology Division

Research output: Contribution to journal › Article › peer-review

176 Scopus citations

Abstract

Background: The His-SYNC pilot trial was the first randomized comparison between His bundle pacing in lieu of a left ventricular lead for cardiac resynchronization therapy (His-CRT) and biventricular pacing (BiV-CRT), but was limited by high rates of crossover. Objective: To evaluate the results of the His-SYNC pilot trial utilizing treatment-received (TR) and per-protocol (PP) analyses. Methods: The His-SYNC pilot was a multicenter, prospective, single-blinded, randomized, controlled trial comparing His-CRT vs BiV-CRT in patients meeting standard indications for CRT (eg, NYHA II–IV patients with QRS >120 ms). Crossovers were required based on prespecified criteria. The primary endpoints analyzed included improvement in QRS duration, left ventricular ejection fraction (LVEF), and freedom from cardiovascular (CV) hospitalization and mortality. Results: Among 41 patients enrolled (aged 64 ± 13 years, 38% female, LVEF 28%, QRS 168 ± 18 ms), 21 were randomized to His-CRT and 20 to BiV-CRT. Crossover occurred in 48% of His-CRT and 26% of BiV-CRT. The most common reason for crossover from His-CRT was inability to correct QRS owing to nonspecific intraventricular conduction delay (n = 5). Patients treated with His-CRT demonstrated greater QRS narrowing compared to BiV (125 ± 22 ms vs 164 ± 25 ms [TR], P < .001;124 ± 19 ms vs 162 ± 24 ms [PP], P < .001). A trend toward higher echocardiographic response was also observed (80 vs 57% [TR], P = .14; 91% vs 54% [PP], P = .078). No significant differences in CV hospitalization or mortality were observed. Conclusions: Patients receiving His-CRT on-treatment demonstrated superior electrical resynchronization and a trend toward higher echocardiographic response than BiV-CRT. Larger prospective studies may be justifiable with refinements in patient selection and implantation techniques to minimize crossovers.

Original language	English (US)
Pages (from-to)	1797-1807
Number of pages	11
Journal	Heart rhythm
Volume	16
Issue number	12
DOIs	https://doi.org/10.1016/j.hrthm.2019.05.009
State	Published - Dec 2019

Funding

Conflicts of Interest: Dr Gaurav Upadhyay has been a speaker for Abbott, Biotronik and Medtronic, and has been a consultant to Abbott, Biotronik, and Medtronic. Dr Pugazhendhi Vijayaraman has been consultant to Abbott, Biotronik, Boston Scientific, and Medtronic; he also has a patent pending for a His delivery tool. Dr Hemal Nayak has been a speaker for Medtronic, Biotronik, and Boston Scientific. Dr Nishant Verma has been a speaker for Biotronik and Medtronic. Dr Gopi Dandamudi has been a speaker and consultant for Medtronic and serves on the advisory board for Biotronik. Dr Parikshit Sharma has been a speaker for Medtronic and has been a consultant for Abbott and Biotronik. Dr Moeen Saleem has been a speaker for Abbott, Medtronic, and Boston Scientific. Dr Faiz Subzposh has been a consultant to Medtronic. Dr Zaid Aziz has been a speaker for Biotronik. Dr Richard Trohman has been a speaker for Abbott, AltaThera Pharmaceuticals, Boston Scientific, Daiichi Sankyo, and Medtronic; he has been an advisor to Boston Scientific; he has received research grants from Abbott, Boston Scientific, Medtronic, Vitatron, and Wyeth-Ayerst/Wyeth Pharmaceuticals; and he is a consultant for Abbott, AltaThera Pharmaceuticals, and Biosense Webster. Dr Knight has been a speaker or consultant for Abbott, Biosense Webster, Biotronik, Boston Scientific, Medtronic, and Philips. Dr Roderick Tung has been a speaker for Abbott and Boston Scientific. Dr John Mandrola, Dr Andrew Beaser, Dr Davide Genovese, Dr Jess Oren, Dr Roberto Lang, Dalise Shatz, and Stephanie Besser report no relevant disclosures. Northwestern University receives institutional support for the training of fellows from Abbott, Biosense Webster, Biotronik, Boston Scientific, and Medtronic. The University of Chicago Medicine receives institutional support for the training of fellows from Abbott, Biotronik, Boston Scientific, and Medtronic. Funding: None.

Keywords

Biventricular pacing
Cardiac resynchronization therapy
Heart failure
His bundle pacing
Left bundle branch block
Nonspecific intraventricular conduction delay

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine
Physiology (medical)

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.hrthm.2019.05.009

Cite this

@article{305d92e6fb2d4c608cf68783fb47b0a6,

title = "On-treatment comparison between corrective His bundle pacing and biventricular pacing for cardiac resynchronization: A secondary analysis of the His-SYNC Pilot Trial",

abstract = "Background: The His-SYNC pilot trial was the first randomized comparison between His bundle pacing in lieu of a left ventricular lead for cardiac resynchronization therapy (His-CRT) and biventricular pacing (BiV-CRT), but was limited by high rates of crossover. Objective: To evaluate the results of the His-SYNC pilot trial utilizing treatment-received (TR) and per-protocol (PP) analyses. Methods: The His-SYNC pilot was a multicenter, prospective, single-blinded, randomized, controlled trial comparing His-CRT vs BiV-CRT in patients meeting standard indications for CRT (eg, NYHA II–IV patients with QRS >120 ms). Crossovers were required based on prespecified criteria. The primary endpoints analyzed included improvement in QRS duration, left ventricular ejection fraction (LVEF), and freedom from cardiovascular (CV) hospitalization and mortality. Results: Among 41 patients enrolled (aged 64 ± 13 years, 38% female, LVEF 28%, QRS 168 ± 18 ms), 21 were randomized to His-CRT and 20 to BiV-CRT. Crossover occurred in 48% of His-CRT and 26% of BiV-CRT. The most common reason for crossover from His-CRT was inability to correct QRS owing to nonspecific intraventricular conduction delay (n = 5). Patients treated with His-CRT demonstrated greater QRS narrowing compared to BiV (125 ± 22 ms vs 164 ± 25 ms [TR], P < .001;124 ± 19 ms vs 162 ± 24 ms [PP], P < .001). A trend toward higher echocardiographic response was also observed (80 vs 57% [TR], P = .14; 91% vs 54% [PP], P = .078). No significant differences in CV hospitalization or mortality were observed. Conclusions: Patients receiving His-CRT on-treatment demonstrated superior electrical resynchronization and a trend toward higher echocardiographic response than BiV-CRT. Larger prospective studies may be justifiable with refinements in patient selection and implantation techniques to minimize crossovers.",

keywords = "Biventricular pacing, Cardiac resynchronization therapy, Heart failure, His bundle pacing, Left bundle branch block, Nonspecific intraventricular conduction delay",

author = "{His-SYNC Investigators} and Upadhyay, {Gaurav A.} and Pugazhendhi Vijayaraman and Nayak, {Hemal M.} and Nishant Verma and Gopi Dandamudi and Sharma, {Parikshit S.} and Moeen Saleem and John Mandrola and Davide Genovese and Oren, {Jess W.} and Subzposh, {Faiz A.} and Zaid Aziz and Andrew Beaser and Dalise Shatz and Stephanie Besser and Lang, {Roberto M.} and Trohman, {Richard G.} and Knight, {Bradley P.} and Roderick Tung",

note = "Publisher Copyright: {\textcopyright} 2019 Heart Rhythm Society",

year = "2019",

month = dec,

doi = "10.1016/j.hrthm.2019.05.009",

language = "English (US)",

volume = "16",

pages = "1797--1807",

journal = "Heart rhythm",

issn = "1547-5271",

publisher = "Elsevier B.V.",

number = "12",

}

TY - JOUR

T1 - On-treatment comparison between corrective His bundle pacing and biventricular pacing for cardiac resynchronization

T2 - A secondary analysis of the His-SYNC Pilot Trial

AU - His-SYNC Investigators

AU - Upadhyay, Gaurav A.

AU - Vijayaraman, Pugazhendhi

AU - Nayak, Hemal M.

AU - Verma, Nishant

AU - Dandamudi, Gopi

AU - Sharma, Parikshit S.

AU - Saleem, Moeen

AU - Mandrola, John

AU - Genovese, Davide

AU - Oren, Jess W.

AU - Subzposh, Faiz A.

AU - Aziz, Zaid

AU - Beaser, Andrew

AU - Shatz, Dalise

AU - Besser, Stephanie

AU - Lang, Roberto M.

AU - Trohman, Richard G.

AU - Knight, Bradley P.

AU - Tung, Roderick

PY - 2019/12

Y1 - 2019/12

N2 - Background: The His-SYNC pilot trial was the first randomized comparison between His bundle pacing in lieu of a left ventricular lead for cardiac resynchronization therapy (His-CRT) and biventricular pacing (BiV-CRT), but was limited by high rates of crossover. Objective: To evaluate the results of the His-SYNC pilot trial utilizing treatment-received (TR) and per-protocol (PP) analyses. Methods: The His-SYNC pilot was a multicenter, prospective, single-blinded, randomized, controlled trial comparing His-CRT vs BiV-CRT in patients meeting standard indications for CRT (eg, NYHA II–IV patients with QRS >120 ms). Crossovers were required based on prespecified criteria. The primary endpoints analyzed included improvement in QRS duration, left ventricular ejection fraction (LVEF), and freedom from cardiovascular (CV) hospitalization and mortality. Results: Among 41 patients enrolled (aged 64 ± 13 years, 38% female, LVEF 28%, QRS 168 ± 18 ms), 21 were randomized to His-CRT and 20 to BiV-CRT. Crossover occurred in 48% of His-CRT and 26% of BiV-CRT. The most common reason for crossover from His-CRT was inability to correct QRS owing to nonspecific intraventricular conduction delay (n = 5). Patients treated with His-CRT demonstrated greater QRS narrowing compared to BiV (125 ± 22 ms vs 164 ± 25 ms [TR], P < .001;124 ± 19 ms vs 162 ± 24 ms [PP], P < .001). A trend toward higher echocardiographic response was also observed (80 vs 57% [TR], P = .14; 91% vs 54% [PP], P = .078). No significant differences in CV hospitalization or mortality were observed. Conclusions: Patients receiving His-CRT on-treatment demonstrated superior electrical resynchronization and a trend toward higher echocardiographic response than BiV-CRT. Larger prospective studies may be justifiable with refinements in patient selection and implantation techniques to minimize crossovers.

AB - Background: The His-SYNC pilot trial was the first randomized comparison between His bundle pacing in lieu of a left ventricular lead for cardiac resynchronization therapy (His-CRT) and biventricular pacing (BiV-CRT), but was limited by high rates of crossover. Objective: To evaluate the results of the His-SYNC pilot trial utilizing treatment-received (TR) and per-protocol (PP) analyses. Methods: The His-SYNC pilot was a multicenter, prospective, single-blinded, randomized, controlled trial comparing His-CRT vs BiV-CRT in patients meeting standard indications for CRT (eg, NYHA II–IV patients with QRS >120 ms). Crossovers were required based on prespecified criteria. The primary endpoints analyzed included improvement in QRS duration, left ventricular ejection fraction (LVEF), and freedom from cardiovascular (CV) hospitalization and mortality. Results: Among 41 patients enrolled (aged 64 ± 13 years, 38% female, LVEF 28%, QRS 168 ± 18 ms), 21 were randomized to His-CRT and 20 to BiV-CRT. Crossover occurred in 48% of His-CRT and 26% of BiV-CRT. The most common reason for crossover from His-CRT was inability to correct QRS owing to nonspecific intraventricular conduction delay (n = 5). Patients treated with His-CRT demonstrated greater QRS narrowing compared to BiV (125 ± 22 ms vs 164 ± 25 ms [TR], P < .001;124 ± 19 ms vs 162 ± 24 ms [PP], P < .001). A trend toward higher echocardiographic response was also observed (80 vs 57% [TR], P = .14; 91% vs 54% [PP], P = .078). No significant differences in CV hospitalization or mortality were observed. Conclusions: Patients receiving His-CRT on-treatment demonstrated superior electrical resynchronization and a trend toward higher echocardiographic response than BiV-CRT. Larger prospective studies may be justifiable with refinements in patient selection and implantation techniques to minimize crossovers.

KW - Biventricular pacing

KW - Cardiac resynchronization therapy

KW - Heart failure

KW - His bundle pacing

KW - Left bundle branch block

KW - Nonspecific intraventricular conduction delay

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DO - 10.1016/j.hrthm.2019.05.009

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AN - SCOPUS:85075084604

SN - 1547-5271

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JO - Heart rhythm

JF - Heart rhythm

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ER -

On-treatment comparison between corrective His bundle pacing and biventricular pacing for cardiac resynchronization: A secondary analysis of the His-SYNC Pilot Trial

Abstract

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

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